St. Jude Medical Receives FDA Approval for Biocor and Biocor Supra Heart Valves

Strategic Insights -

St. Jude Medical, a leading manufacturer of medical devices, has received approval from the U.S. Food and Drug Administration (FDA) for its SJM Biocor(R) and Biocor(R) Supra family of stented tissue valves. This approval marks a significant milestone for the company, allowing it to expand its portfolio of tissue valves and bring its expertise to the U.S. stented tissue valve segment. According to industry estimates, this segment represents 60% of the U.S. market for heart valves.

Key Takeaways:

  • St. Jude Medical has received FDA approval for its SJM Biocor(R) and Biocor(R) Supra stented tissue valves, marking a significant milestone in the company's expansion into the U.S. stented tissue valve segment.
  • The approval allows St. Jude Medical to offer its expertise in mechanical heart valves to the U.S. stented tissue valve segment, which currently represents 60% of the U.S. market for heart valves.
  • The SJM Biocor(R) and Biocor(R) Supra valves feature several unique ease-of-implant characteristics, including the lowest anatomic profile in the U.S. tissue valve market, minimizing aortic wall protrusion and left ventricular outflow tract obstruction in the mitral position.
  • Clinical experience with the SJM Biocor(R) family of stented tissue valves has approached 20 years, with a peer-reviewed article published in the July 2005 issue of the Journal of Heart Valve Disease demonstrating the valve's excellent durability in both the aortic and mitral positions.
  • The company has also received FDA approval for the SJM Biocor(R) Supra stented tissue aortic valve, a supraannular valve implanted above the annulus, which is the supporting structure at the base of each aortic valve leaflet.

Statistics:

  • 60% of the U.S. market for heart valves is represented by the stented tissue valve segment.
  • The SJM Biocor(R) valve has been in clinical use for approximately 20 years.
  • 17 years of clinical experience with the SJM Biocor(R) valve have been demonstrated in a peer-reviewed article published in the July 2005 issue of the Journal of Heart Valve Disease.
  • The SJM Biocor(R) valve has a well-established track record around the world of outstanding clinical performance in both the aortic and mitral valve positions.

Sources:

  • St. Jude Medical press release dated [no date]
  • "Seventeen-Year Experience with the St. Jude Medical Biocor Porcine Bioprosthesis" by Dr. Pia Myken, published in the July 2005 issue of the Journal of Heart Valve Disease.
  • St. Jude Medical's Annual Report to Shareholders for the fiscal year ended December 31, 2004.